Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure
Key facts
- Who runs it
- Montreal Heart Institute
- Where
- Canada2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 20 Nov 2024
- Ended
- 20 Nov 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- Us2.ai (AI-enabled report) handheld echocardiogram
- Record updated
- 22 November 2024
- Why it stopped
- already submitted on NCT05859048
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Male or female ≥40 years of age informed consent and at least two additional risk factors for HF: coronary artery disease [either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis or an epicardial coronary artery (50% left main stem or >70% left anterior descending, circumflex or right coronary artery) diabetes type 1 or type 2, persistent or permanent atrial fibrillation, previous ischemic or embolic stroke peripheral arterial disease (previous surgical or percutaneous revascularization or documented stenosis >50% of major peripheral arterial vessel), chronic kidney disease (estimated glomerular filtration rate <60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR >300mg/g), regular loop diuretic use for >30 days within 12 months COPD (evidenced by one of the following: PFTs showing airway obstruction diagnosis by respiratory physician CT scan reporting presence of emphysema, or treatment with national guideline COPD therapy)
Who cannot take part
- Inability to give informed consent e.g., due to significant cognitive impairment, previous diagnosis of heart failure (this is any diagnosis of heart failure with any ejection fraction of any cause) renal replacement therapy, anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
In the MAPLE-CHF trial, patients will be screened for HF risk factors using electronic medical records of participating family physicians to identify patients with potentially undiagnosed HF. Participants will then undergo a diagnostic evaluation using a blood sample for a hormone specific to the heart, the natriuretic peptide or NT-proBNP; if elevated, a portable cardiac ultrasound (ECHO) with artificial intelligence (AI) interpretation will be done; both NT-proBNP and ECHO are required for diagnosis in patients with signs and symptoms suggestive of HF. This screening ECHO coupled with AI reading from Us2.ai provides a fast, reliable, and inexpensive report, which is particularly important in our context, where waiting lists for such examinations can reach up to one year.
The 2 groups in the trial
- ACTIVE investigational arm (NT-proBNP + AI-ECHO)Treatment being tested
NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent; those with elevated NT-proBNP (≥125pg/ml) will undergo an Us2.ai (AI-enabled report) handheld echocardiogram within one month of NT-proBNP testing. A standard echocardiographic study will be performed if the AI-echo is non-diagnostic.
Treatment: Us2.ai (AI-enabled report) handheld echocardiogram
- CONTROL routine care armOther group
Patients randomized to usual care will undergo standard clinical follow-up, with NT-proBNP and conventional echocardiography prescribed only as per usual practice.
Treatment: Us2.ai (AI-enabled report) handheld echocardiogram
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure.
- Record updated
- 22 November 2024